The Johns Hopkins University (JHU) is a national and international leader in HIV clinical research. The proposed JHU Baltimore-Washington-India (BWI) Clinical Trials Unit (CTU) will integrate three highly productive Clinical Research Sites at the JHU School of Medicine in Baltimore (JHU), Whitman Walker Health in Washington, DC (WWH), and the Byramji-Jeejeebhoy Government Medical College in Pune, India (BJMC). All three sites are currently affiliated with existing NIAID Networks, and with the Division of Infectious Diseases at the JHU School of Medicine, which will serve as the CTU home. These sites are in urban areas most greatly affected by the HIV epidemic, and include the largest HIV clinics in Baltimore and Washington, paired with India's second largest HIV clinic. Building on the existing relationships between these sites allows us to leverage complementary strengths. We expect this CTU to provide scientific leadership, access to important patient populations, and exemplary administrative integrity and cohesion. CTU Scientific Coordinating Committees will bring together expertise from these sites in our strongest fields: Tuberculosis, Hepatitis, HI Cure, HIV Prevention, Clinical Pharmacology, Pediatric & Adolescent Research, Inflammation & End-Organ Complications, Antibiotic Resistance, and Training & Mentorship. These Committees will serve as the creative focus for the CTU by developing new study proposals, identifying and prioritizing studies for site implementation, and encouraging young and international investigators to contribute to novel scientific concepts valued by the Networks we support. Our sites provide access to important and often under-represented populations for NIAID research, including impoverished urban African-Americans and other communities of color, those with a history of intravenous drug use and substance abuse, vulnerable sexually active adolescents and young adult urban MSM and women in Baltimore and Washington, as well as pregnant women, children, adolescents and adults in urban India. Integrating these three sites allows us to optimize the efficiency of our clinical research services with innovative management and communications, while better serving those affected by these epidemics. RELEVANCE: Research on HIV and related infections has improved the treatment and prevention of disease, but much more needs to be done to control the epidemic. The proposed Clinical Trials Unit will join together the most active HIV clinical research sites in Baltimore, Washington, DC, and Pune, India, to optimize patient-oriented research and to access key populations affected by this epidemic for participation in clinical trials.